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510(k) Data Aggregation
K Number
K992608Device Name
ATC OPTION FOR EVITA 2 DURA AND EVITA 4
Manufacturer
DRAGER, INC.
Date Cleared
1999-08-24
(20 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
DRAGER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evita 2 dura and the Evita 4 are time cycled , constant volume, long term, intensive care ventilators for adults and children with a body weight of at least 3 kg.
Intended environment for use of the device
- user facilities ..
- inner clinical transport -
Device Description
The Evita 4 or the Evita 2 dura are time cycled microprocessor-controlled intensive care ventilators. Both devices can be equipped with the ATC option. ATC means automatic tube compensation. This ventilation mode extension provides a compensation of an endotracheal or tracheostomy tube. It calculates and displays the tracheal pressure from a mathematical model on the basis of selected type of tube and tube internal diameter.
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K Number
K984577Device Name
DRAGER OXYLOG 2000
Manufacturer
DRAGER, INC.
Date Cleared
1999-01-22
(30 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
DRAGER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oxylog 2000 is a time cycled, volume constant transport and emergency ventilator for patients with tidal volumes starting at 100 mL. With applications in: mobile emergency and primary care of emergency patients, patient transports in emergency rescue vehicles or by helicopter, patient transfers by road or air, inner hospital transport of ventilated patients, emergency room, secondary transports between hospitals.
Device Description
The device is a software controlled and time cycled transport and emergency ventilator. It can be equipped with an external power supply for stationary operation in hospitals and is equipped with a NiCd Battery Pack for the during transport. The Oxylog 2000 has 5 rotary knobs for the adjustment of the ventilator rate, tidal volume, I:E ratio, inspiratory pressure limitation and peep.
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K Number
K983219Device Name
NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900
Manufacturer
DRAGER, INC.
Date Cleared
1998-12-07
(84 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
DRAGER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NeoFlow - Neonatal mode with base flow.
The Evita 4 / 2 Dura with NeoFlow Option is a long-term ventilator to be used for intensive care and inner clinical transport of adults, children, infants and neonates with a minimum body weight of 0.5 kg.
The device is microprocessor controlled and provides the following ventilation modes:
- CMV/assist Controlled Mandatory Ventilation Controlled and assisted volume constant ventilation, with the options: - CPPV Continuous Positive Pressure Ventilation - PLV Pressure Limited Ventilation - AutoFlow For automatic regulation of inspiratory flow - IRV Inversed Ratio Ventilation
- SIMV Synchronised Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options: - PLV - AutoFlow
- MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options: - PLV - AutoFlow
- SB Spontaneous Breathing Spontaneous breathing at ambient pressure
- CPAP Continuos Positive Airway Pressure Spontaneous breathing with positive airway pressure
- ASB/PSV Assisted Spontaneous Breathing / Pressure Support Ventilation Pressure supported spontaneous breathing
- PCV+ Pressure controlled ventilation, combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level
- APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable.
- Apnea Ventilation For switching over automatically to volume controlled ventilation if breathing stops.
- ILV Independent Lung Ventilation Separate, differentiated synchronised ventilation with one Evita 4 / 2 Dura for each lung.
Device Description
The Evita 4 NeoFlow option extends the patient range of the Evita 4 ventilator to neonates with a minimum weight of 0,5 kg.
The Evita 4 equipped with the NeoFlow option provides the following ventilation modes.
- CMV/assist Controlled Mandatory Ventilation Controlled and assisted volume contant ventilation with the options: - CPV Continuous Positive Pressure Ventilation - PLV Pressure Limited Ventilation - AutoFlow For automatic regulation of inspiratory flow - IRV Inversed Ratio Ventilation
- SIMV Synchronized Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options: - PLV - AutoFlow
- MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options: - PLV - AutoFlow
- SB Spontaneous Breathing Spontaneous breathing at ambient pressure
- CPAP Continuous Positive Airway Pressure Spontaneous breathing with positive airway pressure
- ASB/PSV Assisted Spontaneous Breathing / Pressure Support Ventilation Pressure supported spontaneous breathing
- PCV+ Pressure Controlled Ventilation Pressure controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level
- APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable
- Apnea Ventilation For switching over automatically to volume controlled mandatory ventilation if breathing stops
- ILV Independent Lung Ventilation Separate, differentiated, synchronized ventilation with one Evita 4 for each lung.
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K Number
K982789Device Name
MEDICAL AIR COMPRESSOR, MODEL # 8413419
Manufacturer
DRAGER, INC.
Date Cleared
1998-10-29
(80 days)
Product Code
BTI, MED
Regulation Number
868.6250Why did this record match?
Applicant Name (Manufacturer) :
DRAGER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Air compressor supplying compressed air for medical ventilators.
Device Description
The device is electric and produces compressed air from the normal environment to supply compressed air for medical ventilators.
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K Number
K980642Device Name
EVITA 4 (8411900)
Manufacturer
DRAGER, INC.
Date Cleared
1998-09-04
(197 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
DRAGER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Evita 4 is a time cycled, constant volume, long term, intensive care ventilator for adults and children with a body weight of at least 3 kg.
Intended Environment for the device:
- hospital use
- inner clinical transport
Device Description
The Evita 4 with the Software version 3.0 is a time cycled, constant volume ventilator The Evita + with the Oct.ware is microprocessor controlled and provides the following ventilation modes:
- CMV/assist
- SIMV
- MMV
- SB
- CPAP
- ASB/PSV
- PCV+
- APRV
- Apnea Ventilation
- ILV
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K Number
K974176Device Name
BABYLOG 8000 PLUS
Manufacturer
DRAGER, INC.
Date Cleared
1998-06-17
(223 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
DRAGER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Babylog 8000 plus is a long term ventilator to be used in intensive care of premature and newborn babies and of infants up to 10 kg (22 lbs).
The device provides the following ventilation modes:
CMV Continuous Mandatory Ventilation
AIC Assist Control Ventilation
SIMV Synchronized Intermittent Mandatory Ventilation
Pressure Support Ventilation (available option) PSV
CPAP Continuous Positive Airway Pressure
Ventilation mode extension:
VG Volume Guarantee (available option), Volume controlled ventilation
VIVE Variable Inspiratory, Variable Expiratory Flow
Device Description
The Babylog 8000 plus is an enhanced version of its predecessor Babylog 8000. It is a long-term, microprocessor-controlled, intensive care ventilator for premature and newborn babies, as well as for infants weighing up to about 10 kg.
The Babylog 8000 plus ventilates according to the continuous-flow principle with either time control or volume control, depending on the ventilation mode, and pressure limitation. Oxygen is metered out by the integrated air/O2 mixer.
A variety of the device functions are monitored in operation to make sure that safety-relevant failures are detected and safety for the patient is maintained.
The analog and digital interface is optionally available for connecting the Babylog 8000 plus to a device like a patient monitor or computer so that measured values and settings can be transferred to such equipment.
The ventilator can also be combined with a medicament nebulizer.
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K Number
K971198Device Name
BABYTHERM 8004 BABYTHERM 8010
Manufacturer
DRAGER, INC.
Date Cleared
1997-10-03
(186 days)
Product Code
FMT
Regulation Number
880.5130Why did this record match?
Applicant Name (Manufacturer) :
DRAGER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Babytherm 8004 / 8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 lbs. It is intended for use in delivery rooms, operating theatres, maternity and obstetric units, neonatal wards, neonatal and paediatric intensive care units. Both Systems can be equipped with the optional phototherapy system for treatment of Hyperbilirubinemia.
Device Description
Babytherm 8004 / 8010 is a warmer system for infants that provides a combination of a heated mattress (Babytherm 8010, only), a radiant heater and an optional phototherapy system. The radiant heater is in a fixed position over the mattress and is equipped with an examination light. The phototherapy system can be installed by the manufacturer or by the biomedical engineer in the housing of the radiant heater. Babytherm 8004 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". Babytherm 8010 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". The Babytherm 8010 also has a heated gel mattress for conductive warmth.
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K Number
K970165Device Name
EVITA 2 DURA
Manufacturer
DRAGER, INC.
Date Cleared
1997-08-26
(222 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
DRAGER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Evita 2 dura is a long-term ventilator for the intensive care ventilation of patients with a body weight of at least 3 kg up to 200 Kg.
The device is microprocessor-controlled and provides the following ventilation modes :
- CMV - Intermittent Positive Pressure Ventilation Controlled and assisted volume-constant ventilation
- SIMV Synchronized Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing
- MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patient's minute volume requirement.
- CPAP Continuous Positive Airway Pressure Spontaneous breathing with positive airway pressure and adjustable pressure support.
- PCV+ Pressure Controlled Ventilation Pressure-controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure support from CPAP level.
- APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable.
Furthermore Evita 2 dura offers the following special ventilation modes :
- Apnea ventilation For switching over automatically to volume-controlled ventilation if breathing stops.
- ILV Independent Lung Ventilation, optional Separate, differentiated, synchronised ventilation with one Evita 3 unit for each lung.
Application range
- Intensive care units
- Inner-clinical transport
Device Description
The Evita 2 dura is a time cycled, constant volume ventilator for long term use in intensive care and inner clinical transport. The device is microprocessor controlled and provides the following ventilation modes:
- CMV/assist Controlled Mandatory Ventilation Controlled and assisted volume contant ventilation with the options: - CPV Continuous Positive Pressure Ventilation - PLV Pressure Limited Ventilation - AutoFlow For automatic regulation of inspiratory flow - IRV Inversed Ratio Ventilation
- SIMV Synchronized Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options: - PLV - AutoFlow
- MMV Mandatory Minute Volume Ventilation Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options: - PLV - AutoFlow
- SB Spontaneous Breathing Spontaneous breathing at ambient pressure
- CPAP Continuous Positive Airway Pressure Spontaneous breathing with positive airway pressure
- ASB/PSV Assisted Spontaneous Breathing / Pressure Support Ventilation Pressure supported spontaneous breathing
- PCV+ Pressure Controlled Ventilation Pressure controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level
- APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable
- Apnea Ventilation For switching over automatically to volume controlled mandatory ventilation if breathing stops
- ILV Independent Lung Ventilation Separate, differentiated, synchronized ventilation with one Evita 2 dura for each lung
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K Number
K954204Device Name
DRAGER INCUBATOR 8000 IC
Manufacturer
DRAGER, INC.
Date Cleared
1997-04-25
(597 days)
Product Code
FMZ
Regulation Number
880.5400Why did this record match?
Applicant Name (Manufacturer) :
DRAGER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961687Device Name
EVITA 4
Manufacturer
DRAGER, INC.
Date Cleared
1996-12-13
(226 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
DRAGER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
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